First the bad news: unfortunately our preliminary application to Wellcome, submitted at the start of the year, was turned down. No feedback was given so we don’t know why it was rejected.

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Thanks Wellcome trust . (It is very disappointing that our ME charities are not rejecting MEGA similarly and still supporting MEGA.)

But some bad news.

The good news is that, in the last couple of weeks, the Scientific Team and the Patient Advisory Grouphave prepared a new outline application for further funding. With a short deadline it was tough going at times, but having had substantial input, the Patient Advisory Group are very pleased with the submission.

A very productive meeting between Prof Esther Crawley, Prof Julia Newton and the Patient Advisory Group was held early last week with some important points agreed:

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Now let's assess whether the rejection of the application and the three patient advisors leaving has really made a difference:

Both the Scientific Team and the Patient Advisory Group agree that it is absolutely essential that we collect data from those most severely affected by M.E., and those affected long term. This will require home visits which are very expensive, and the financial limit of the current application will not cover this.

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They could just use the existing biobank that has collected samples from severely ill. Sure this isn't going to be a random sample, but their patient recruitment approach isn't random either.

Post-exertional malaise will be a prerequisite for inclusion in the bioresource. If successfully funded, a detailed definition of post-exertional malaise will be determined primarily by the Patient Advisory Group in conjunction with the ME/CFS specialists on the Scientific Team.

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This is dishonest and red flag. We want to know how PEM is going to be defined because we think you're trying to sneak a misleading definition of PEM into the study.

Those whose samples are collected for the bioresource will have their diagnoses and severity of illness confirmed and recorded at point of collection. Several case definitions will be used to categorise patients and it will be clear which case definition any given patient fits into. When analysing results of tests undertaken on samples from the bioresource, the Scientific Team will be clear which subset of patients the results specifically relate to (we will address this in more detail in a forthcoming blog post).

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Similar story here. By refusing to disclose details about this important aspect, they maintain full control over who is actually going to be studied. They might just decide that CFS is all about fatigue and incompatible with symptom x where x is something commonly found in subset y of a ME/CFS sample.

Isn't it strange how the behaviour of the MEGA team is fully consistent with either:

a) An incompetent PI that can't come up with a good plan because they have no real idea of what they're doing.
b) A dishonest PI that is trying to sell us a study we won't like.

I believe this would be the largest ME/CFS study ever. Why is it run by an incompetent or lying PI?

I wonder if MEGA will be providing an update on why three members of the Patient Advisory Group resigned?

In my view, over the last three months, the PAG has not been permitted to carry out the functions publicly ascribed to it. As an advocate for severely ill ME patients this puts me in a difficult position. Members of the PAG have been working and studying incredibly hard, both individually and collectively, in order to be in the best and most informed position to assist the MEGA team who, as a group, have very little knowledge of ME/CFS. I believe we are all desperate for good quality, relevant research to be done on ME and ME/CFS, so I have found it intensely frustrating to find our efforts to engage thwarted at every step. I have not felt that the PI representing the MEGA researchers has a genuine wish for a meaningful engagement with the PAG, nor for the collaborative relationship many PAG members hoped for and have been working towards. Now, sadly, my impression is that the PAG was hastily appointed at the last minute as a cynical attempt to try to make bioresource bids look more appealing to funders and to reassure patients.

I have not found an honest and open environment for discussion between PAG and PI.

Esther Crawley is poison to any research project that needs support from patients.

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I’m still trying to work out how to report what happened without falling foul of the confidentiality clause.

WTF is the confidentially clause here.

Anyone got a copy of it? This is really dodgy! Trying to silence people like this.

This MEGA project had got so many red warning signs on it , it is hazardous for pwme, i cant believe anyone in the ME charities could support it. (I obviously dont include IFME in this comment. I see our good friend Sonya wrote this update.)

It would be useful to find out why MEGA was rejected by the Wellcome Trust, but I guess they won't tell the public anything.

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It would seem from all external appearances, that EC is taking over from Holgate.
There's no mention I could see of Holgate involved in the new bid.
Is Holgate retiring?

On another point...
I note MEGA suggest that PEM will be a prerequisite. Without definition, PEM could be a bit of tireness just after exertion, so a symptom of a healthy person; or ongoing tireness immediately following exertion, so a symptom of other illnesses also.
I don't know what criteria they settled on but if they are following NICE Guidance as was suggested at one point, PEM with an onset typically delayed by 24 hours or more is a prerequisite prior to diagnosis. A very different symptom and one not present in most other illnesses.

I’m still trying to work out how to report what happened without falling foul of the confidentiality clause.

WTF is the confidentially clause here.

Anyone got a copy of it? This is really dodgy! Trying to silence people like this.

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I was equally concerned by this.

My thinking is that the PAG group were there to represent the views and needs of the patient community. There should be feedback between those on the PAG and the patient community whose voices they represent. To me, this would be the most helpful and healthy way to progress especially where patient trust has been so terribly abused in the past.

Three Patient Advisory Group members recently decided to leave the group. Their much valued contributions will be missed and their reasons for leaving have been taken on board.

Since their departure, valuable progress has been made and we are happy to report that, despite the initial rushed formation of the Patient Advisory Group and the pressure caused by tight application deadlines, things have really picked up and are beginning to fly. Enthusiasm among Patient Advisory Group members is high, the Scientific Team remains focused, and we all wait with fingers crossed for a positive outcome to this preliminary funding application.

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How to be nasty while sounding nice about those people who left the PAG.

My thinking is that the PAG group were there to represent the views and needs of the patient community. There should be feedback between those on the PAG and the patient community whose voices they represent. To me, this would be the most helpful and healthy way to progress especially where patient trust has been so terribly abused in the past.

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Whatever justifiable reason is there for silencing members of a PAG? I find this very disturbing.

On another point...
I note MEGA suggest that PEM will be a prerequisite. Without definition, PEM could be a bit of tireness just after exertion, so a symptom of a healthy person; or ongoing tireness immediately following exertion, so a symptom of other illnesses also.
I don't know what criteria they settled on but if they are following NICE Guidance as was suggested at one point, PEM with an onset typically delayed by 24 hours or more is a prerequisite prior to diagnosis. A very different symptom and one not present in most other illnesses.

Does anyone know what their criteria for PEM is?

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Their update says

Post-exertional malaise will be a prerequisite for inclusion in the bioresource. If successfully funded, a detailed definition of post-exertional malaise will be determined primarily by the Patient Advisory Group in conjunction with the ME/CFS specialists on the Scientific Team.

It would seem from all external appearances, that EC is taking over from Holgate.
There's no mention I could see of Holgate involved in the new bid.
Is Holgate retiring?

On another point...
I note MEGA suggest that PEM will be a prerequisite. Without definition, PEM could be a bit of tireness just after exertion, so a symptom of a healthy person; or ongoing tireness immediately following exertion, so a symptom of other illnesses also.
I don't know what criteria they settled on but if they are following NICE Guidance as was suggested at one point, PEM with an onset typically delayed by 24 hours or more is a prerequisite prior to diagnosis. A very different symptom and one not present in most other illnesses.

Does anyone know what their criteria for PEM is?

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I have already seen written on a few occasions that (according to them) PEM can be post exertional fatigue! What feckin person doesn't feel fatigue after exercise, if you don't you aren't trying hard enough? God help us!

These people are so frightening, they really scare me. Doctors are supposed to help us not terrify us.